Trial Outcomes & Findings for Adoptive Cell Therapy Across Cancer Diagnoses (NCT NCT03296137)

Last Updated: 2024-10-26

Results Overview

Determine the safety of the administration of TIL therapy including checkpoint inhibitors, lymphodepleting chemotherapy and Interleukin-2 for patients with cancer by reporting grade \>2 adverse events according to CTCAE v. 4.0

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

25 participants

Primary outcome timeframe

Up to 2,5 years from begin of study

Results posted on

2024-10-26

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants Autologous tumor-infiltrating lymphocytes: Tumor-infiltrating lymphocytes grown ex-vivo from resected from cancer tissue and reapplied to the patient via an intravenous infusion. Ipilimumab: One treatment with ipilimumab (3 mg/kg) prior to tumor resection. Nivolumab: 4 doses of nivolumab. Starting 2 days prior to TIL infusion and every 2 weeks hereafter. proleukin: 2 MIE s.c. injection, after TIL infusion and continuing for 2 weeks Cyclophosphamide: 2 doses (60 mg/kg) prior to TIL infusion Fludara: 5 doses (25 mg/m2) prior to TIL infusion
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=25 Participants Autologous tumor-infiltrating lymphocytes: Tumor-infiltrating lymphocytes grown ex-vivo from resected from cancer tissue and reapplied to the patient via an intravenous infusion. Ipilimumab: One treatment with ipilimumab (3 mg/kg) prior to tumor resection. Nivolumab: 4 doses of nivolumab. Starting 2 days prior to TIL infusion and every 2 weeks hereafter. proleukin: 2 MIE s.c. injection, after TIL infusion and continuing for 2 weeks Cyclophosphamide: 2 doses (60 mg/kg) prior to TIL infusion Fludara: 5 doses (25 mg/m2) prior to TIL infusion
Age, Categorical <=18 years	0 Participants n=25 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=25 Participants
Age, Categorical >=65 years	3 Participants n=25 Participants
Sex: Female, Male Female	14 Participants n=25 Participants
Sex: Female, Male Male	11 Participants n=25 Participants

PRIMARY outcome

Timeframe: Up to 2,5 years from begin of study

Population: Patients who received TIL therapy

Outcome measures

Outcome measures
Measure	All Participants n=25 Participants Autologous tumor-infiltrating lymphocytes: Tumor-infiltrating lymphocytes grown ex-vivo from resected from cancer tissue and reapplied to the patient via an intravenous infusion. Ipilimumab: One treatment with ipilimumab (3 mg/kg) prior to tumor resection. Nivolumab: 4 doses of nivolumab. Starting 2 days prior to TIL infusion and every 2 weeks hereafter. proleukin: 2 MIE s.c. injection, after TIL infusion and continuing for 2 weeks Cyclophosphamide: 2 doses (60 mg/kg) prior to TIL infusion Fludara: 5 doses (25 mg/m2) prior to TIL infusion
Number of Participants and Type of Reported Adverse Events Neutropenia	25 Participants
Number of Participants and Type of Reported Adverse Events Trombocytopenia	22 Participants
Number of Participants and Type of Reported Adverse Events Anemia	22 Participants
Number of Participants and Type of Reported Adverse Events Infection	6 Participants
Number of Participants and Type of Reported Adverse Events Hyponatremia	2 Participants
Number of Participants and Type of Reported Adverse Events Hemorrhagic cystitis	1 Participants
Number of Participants and Type of Reported Adverse Events Fatique	6 Participants
Number of Participants and Type of Reported Adverse Events Vertigo	1 Participants
Number of Participants and Type of Reported Adverse Events Performance status drop	4 Participants
Number of Participants and Type of Reported Adverse Events Thrombosis	1 Participants
Number of Participants and Type of Reported Adverse Events Fever	16 Participants
Number of Participants and Type of Reported Adverse Events Dyspnea	6 Participants
Number of Participants and Type of Reported Adverse Events Hepatitis	2 Participants
Number of Participants and Type of Reported Adverse Events Colitis	2 Participants
Number of Participants and Type of Reported Adverse Events Transaminase elevation	2 Participants
Number of Participants and Type of Reported Adverse Events Vomiting	2 Participants
Number of Participants and Type of Reported Adverse Events Hallucination	1 Participants
Number of Participants and Type of Reported Adverse Events Elevated creatinine	1 Participants

SECONDARY outcome

Timeframe: Until study completion

Days of follow-up from TIL infusion until progressive cancer disease, end of follow-up or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Outcome measures

Outcome measures
Measure	All Participants n=25 Participants Autologous tumor-infiltrating lymphocytes: Tumor-infiltrating lymphocytes grown ex-vivo from resected from cancer tissue and reapplied to the patient via an intravenous infusion. Ipilimumab: One treatment with ipilimumab (3 mg/kg) prior to tumor resection. Nivolumab: 4 doses of nivolumab. Starting 2 days prior to TIL infusion and every 2 weeks hereafter. proleukin: 2 MIE s.c. injection, after TIL infusion and continuing for 2 weeks Cyclophosphamide: 2 doses (60 mg/kg) prior to TIL infusion Fludara: 5 doses (25 mg/m2) prior to TIL infusion
Time to Disease Progression	89 Days Interval 12.0 to 211.0

SECONDARY outcome

Timeframe: Until study completion

Duration of survival measured in days after adoptive cell therapy until death or end of follow-up/censoring.

Outcome measures

Outcome measures
Measure	All Participants n=25 Participants Autologous tumor-infiltrating lymphocytes: Tumor-infiltrating lymphocytes grown ex-vivo from resected from cancer tissue and reapplied to the patient via an intravenous infusion. Ipilimumab: One treatment with ipilimumab (3 mg/kg) prior to tumor resection. Nivolumab: 4 doses of nivolumab. Starting 2 days prior to TIL infusion and every 2 weeks hereafter. proleukin: 2 MIE s.c. injection, after TIL infusion and continuing for 2 weeks Cyclophosphamide: 2 doses (60 mg/kg) prior to TIL infusion Fludara: 5 doses (25 mg/m2) prior to TIL infusion
Overall Survival	227 Days Interval 50.0 to 870.0

SECONDARY outcome

Timeframe: The patients were evaluated every 6-12 weeks (median 90 days) and after therapy and until study completion (max 220 days).

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CAT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	All Participants n=25 Participants Autologous tumor-infiltrating lymphocytes: Tumor-infiltrating lymphocytes grown ex-vivo from resected from cancer tissue and reapplied to the patient via an intravenous infusion. Ipilimumab: One treatment with ipilimumab (3 mg/kg) prior to tumor resection. Nivolumab: 4 doses of nivolumab. Starting 2 days prior to TIL infusion and every 2 weeks hereafter. proleukin: 2 MIE s.c. injection, after TIL infusion and continuing for 2 weeks Cyclophosphamide: 2 doses (60 mg/kg) prior to TIL infusion Fludara: 5 doses (25 mg/m2) prior to TIL infusion
Overall Response Rate	2 Participants

Adverse Events

Treated Participants

Serious events: 9 serious events

Other events: 25 other events

Deaths: 23 deaths

Serious adverse events

Serious adverse events
Measure	Treated Participants n=25 participants at risk Autologous tumor-infiltrating lymphocytes: Tumor-infiltrating lymphocytes grown ex-vivo from resected from cancer tissue and reapplied to the patient via an intravenous infusion. Ipilimumab: One treatment with ipilimumab (3 mg/kg) prior to tumor resection. Nivolumab: 4 doses of nivolumab. Starting 2 days prior to TIL infusion and every 2 weeks hereafter. proleukin: 2 MIE s.c. injection, after TIL infusion and continuing for 2 weeks Cyclophosphamide: 2 doses (60 mg/kg) prior to TIL infusion Fludara: 5 doses (25 mg/m2) prior to TIL infusion
Hepatobiliary disorders Elevated bilirubin	4.0% 1/25 • Number of events 1 • The data was collected throughout the duration of the clinical trial. From October 2017 and until study Completion in july, 2020. For the individual patient, the reporting started at the study enrolment and ended with study exclusion but with a minimum of 6 months follow-up after the adoptive cell therapy or until study completion. Information on adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter. Patients were routinely screening for anticipated adverse events. The screening was performed every 6 weeks until the first 3 months and hereafter every 3 months for up to 2.5 years.
Infections and infestations Urinary tract infection	4.0% 1/25 • Number of events 1 • The data was collected throughout the duration of the clinical trial. From October 2017 and until study Completion in july, 2020. For the individual patient, the reporting started at the study enrolment and ended with study exclusion but with a minimum of 6 months follow-up after the adoptive cell therapy or until study completion. Information on adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter. Patients were routinely screening for anticipated adverse events. The screening was performed every 6 weeks until the first 3 months and hereafter every 3 months for up to 2.5 years.
Blood and lymphatic system disorders Refractory trombocytopenia	4.0% 1/25 • Number of events 1 • The data was collected throughout the duration of the clinical trial. From October 2017 and until study Completion in july, 2020. For the individual patient, the reporting started at the study enrolment and ended with study exclusion but with a minimum of 6 months follow-up after the adoptive cell therapy or until study completion. Information on adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter. Patients were routinely screening for anticipated adverse events. The screening was performed every 6 weeks until the first 3 months and hereafter every 3 months for up to 2.5 years.
Skin and subcutaneous tissue disorders Chylos	4.0% 1/25 • Number of events 1 • The data was collected throughout the duration of the clinical trial. From October 2017 and until study Completion in july, 2020. For the individual patient, the reporting started at the study enrolment and ended with study exclusion but with a minimum of 6 months follow-up after the adoptive cell therapy or until study completion. Information on adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter. Patients were routinely screening for anticipated adverse events. The screening was performed every 6 weeks until the first 3 months and hereafter every 3 months for up to 2.5 years.
Infections and infestations Neutropenic fever	4.0% 1/25 • Number of events 2 • The data was collected throughout the duration of the clinical trial. From October 2017 and until study Completion in july, 2020. For the individual patient, the reporting started at the study enrolment and ended with study exclusion but with a minimum of 6 months follow-up after the adoptive cell therapy or until study completion. Information on adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter. Patients were routinely screening for anticipated adverse events. The screening was performed every 6 weeks until the first 3 months and hereafter every 3 months for up to 2.5 years.
Blood and lymphatic system disorders Thrombosis in central katheter	4.0% 1/25 • Number of events 1 • The data was collected throughout the duration of the clinical trial. From October 2017 and until study Completion in july, 2020. For the individual patient, the reporting started at the study enrolment and ended with study exclusion but with a minimum of 6 months follow-up after the adoptive cell therapy or until study completion. Information on adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter. Patients were routinely screening for anticipated adverse events. The screening was performed every 6 weeks until the first 3 months and hereafter every 3 months for up to 2.5 years.
Infections and infestations Upper respiratory tract infection	4.0% 1/25 • Number of events 1 • The data was collected throughout the duration of the clinical trial. From October 2017 and until study Completion in july, 2020. For the individual patient, the reporting started at the study enrolment and ended with study exclusion but with a minimum of 6 months follow-up after the adoptive cell therapy or until study completion. Information on adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter. Patients were routinely screening for anticipated adverse events. The screening was performed every 6 weeks until the first 3 months and hereafter every 3 months for up to 2.5 years.
Gastrointestinal disorders Colitis	8.0% 2/25 • Number of events 3 • The data was collected throughout the duration of the clinical trial. From October 2017 and until study Completion in july, 2020. For the individual patient, the reporting started at the study enrolment and ended with study exclusion but with a minimum of 6 months follow-up after the adoptive cell therapy or until study completion. Information on adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter. Patients were routinely screening for anticipated adverse events. The screening was performed every 6 weeks until the first 3 months and hereafter every 3 months for up to 2.5 years.
General disorders Addisions crisis	4.0% 1/25 • Number of events 1 • The data was collected throughout the duration of the clinical trial. From October 2017 and until study Completion in july, 2020. For the individual patient, the reporting started at the study enrolment and ended with study exclusion but with a minimum of 6 months follow-up after the adoptive cell therapy or until study completion. Information on adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter. Patients were routinely screening for anticipated adverse events. The screening was performed every 6 weeks until the first 3 months and hereafter every 3 months for up to 2.5 years.
Respiratory, thoracic and mediastinal disorders Dyspnea	4.0% 1/25 • Number of events 1 • The data was collected throughout the duration of the clinical trial. From October 2017 and until study Completion in july, 2020. For the individual patient, the reporting started at the study enrolment and ended with study exclusion but with a minimum of 6 months follow-up after the adoptive cell therapy or until study completion. Information on adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter. Patients were routinely screening for anticipated adverse events. The screening was performed every 6 weeks until the first 3 months and hereafter every 3 months for up to 2.5 years.
Infections and infestations Infection unknown focus	4.0% 1/25 • Number of events 1 • The data was collected throughout the duration of the clinical trial. From October 2017 and until study Completion in july, 2020. For the individual patient, the reporting started at the study enrolment and ended with study exclusion but with a minimum of 6 months follow-up after the adoptive cell therapy or until study completion. Information on adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter. Patients were routinely screening for anticipated adverse events. The screening was performed every 6 weeks until the first 3 months and hereafter every 3 months for up to 2.5 years.

Other adverse events

Other adverse events
Measure	Treated Participants n=25 participants at risk Autologous tumor-infiltrating lymphocytes: Tumor-infiltrating lymphocytes grown ex-vivo from resected from cancer tissue and reapplied to the patient via an intravenous infusion. Ipilimumab: One treatment with ipilimumab (3 mg/kg) prior to tumor resection. Nivolumab: 4 doses of nivolumab. Starting 2 days prior to TIL infusion and every 2 weeks hereafter. proleukin: 2 MIE s.c. injection, after TIL infusion and continuing for 2 weeks Cyclophosphamide: 2 doses (60 mg/kg) prior to TIL infusion Fludara: 5 doses (25 mg/m2) prior to TIL infusion
Blood and lymphatic system disorders Neutropenia	100.0% 25/25 • Number of events 28 • The data was collected throughout the duration of the clinical trial. From October 2017 and until study Completion in july, 2020. For the individual patient, the reporting started at the study enrolment and ended with study exclusion but with a minimum of 6 months follow-up after the adoptive cell therapy or until study completion. Information on adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter. Patients were routinely screening for anticipated adverse events. The screening was performed every 6 weeks until the first 3 months and hereafter every 3 months for up to 2.5 years.
Blood and lymphatic system disorders Trombocytopenia	92.0% 23/25 • The data was collected throughout the duration of the clinical trial. From October 2017 and until study Completion in july, 2020. For the individual patient, the reporting started at the study enrolment and ended with study exclusion but with a minimum of 6 months follow-up after the adoptive cell therapy or until study completion. Information on adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter. Patients were routinely screening for anticipated adverse events. The screening was performed every 6 weeks until the first 3 months and hereafter every 3 months for up to 2.5 years.
Blood and lymphatic system disorders Anemia	88.0% 22/25 • Number of events 28 • The data was collected throughout the duration of the clinical trial. From October 2017 and until study Completion in july, 2020. For the individual patient, the reporting started at the study enrolment and ended with study exclusion but with a minimum of 6 months follow-up after the adoptive cell therapy or until study completion. Information on adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter. Patients were routinely screening for anticipated adverse events. The screening was performed every 6 weeks until the first 3 months and hereafter every 3 months for up to 2.5 years.
General disorders Fatigue	80.0% 20/25 • Number of events 20 • The data was collected throughout the duration of the clinical trial. From October 2017 and until study Completion in july, 2020. For the individual patient, the reporting started at the study enrolment and ended with study exclusion but with a minimum of 6 months follow-up after the adoptive cell therapy or until study completion. Information on adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter. Patients were routinely screening for anticipated adverse events. The screening was performed every 6 weeks until the first 3 months and hereafter every 3 months for up to 2.5 years.
General disorders Nausea	96.0% 24/25 • Number of events 24 • The data was collected throughout the duration of the clinical trial. From October 2017 and until study Completion in july, 2020. For the individual patient, the reporting started at the study enrolment and ended with study exclusion but with a minimum of 6 months follow-up after the adoptive cell therapy or until study completion. Information on adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter. Patients were routinely screening for anticipated adverse events. The screening was performed every 6 weeks until the first 3 months and hereafter every 3 months for up to 2.5 years.
Gastrointestinal disorders Vomiting	48.0% 12/25 • The data was collected throughout the duration of the clinical trial. From October 2017 and until study Completion in july, 2020. For the individual patient, the reporting started at the study enrolment and ended with study exclusion but with a minimum of 6 months follow-up after the adoptive cell therapy or until study completion. Information on adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter. Patients were routinely screening for anticipated adverse events. The screening was performed every 6 weeks until the first 3 months and hereafter every 3 months for up to 2.5 years.
Gastrointestinal disorders Diarrhea	40.0% 10/25 • The data was collected throughout the duration of the clinical trial. From October 2017 and until study Completion in july, 2020. For the individual patient, the reporting started at the study enrolment and ended with study exclusion but with a minimum of 6 months follow-up after the adoptive cell therapy or until study completion. Information on adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter. Patients were routinely screening for anticipated adverse events. The screening was performed every 6 weeks until the first 3 months and hereafter every 3 months for up to 2.5 years.
Gastrointestinal disorders Obstipation	24.0% 6/25 • The data was collected throughout the duration of the clinical trial. From October 2017 and until study Completion in july, 2020. For the individual patient, the reporting started at the study enrolment and ended with study exclusion but with a minimum of 6 months follow-up after the adoptive cell therapy or until study completion. Information on adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter. Patients were routinely screening for anticipated adverse events. The screening was performed every 6 weeks until the first 3 months and hereafter every 3 months for up to 2.5 years.
Infections and infestations Oral mucositis	56.0% 14/25 • Number of events 23 • The data was collected throughout the duration of the clinical trial. From October 2017 and until study Completion in july, 2020. For the individual patient, the reporting started at the study enrolment and ended with study exclusion but with a minimum of 6 months follow-up after the adoptive cell therapy or until study completion. Information on adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter. Patients were routinely screening for anticipated adverse events. The screening was performed every 6 weeks until the first 3 months and hereafter every 3 months for up to 2.5 years.
Skin and subcutaneous tissue disorders Maculopapular rash	32.0% 8/25 • Number of events 10 • The data was collected throughout the duration of the clinical trial. From October 2017 and until study Completion in july, 2020. For the individual patient, the reporting started at the study enrolment and ended with study exclusion but with a minimum of 6 months follow-up after the adoptive cell therapy or until study completion. Information on adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter. Patients were routinely screening for anticipated adverse events. The screening was performed every 6 weeks until the first 3 months and hereafter every 3 months for up to 2.5 years.
General disorders Febrile neutropenia	92.0% 23/25 • Number of events 25 • The data was collected throughout the duration of the clinical trial. From October 2017 and until study Completion in july, 2020. For the individual patient, the reporting started at the study enrolment and ended with study exclusion but with a minimum of 6 months follow-up after the adoptive cell therapy or until study completion. Information on adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter. Patients were routinely screening for anticipated adverse events. The screening was performed every 6 weeks until the first 3 months and hereafter every 3 months for up to 2.5 years.
Skin and subcutaneous tissue disorders Edema	12.0% 3/25 • Number of events 3 • The data was collected throughout the duration of the clinical trial. From October 2017 and until study Completion in july, 2020. For the individual patient, the reporting started at the study enrolment and ended with study exclusion but with a minimum of 6 months follow-up after the adoptive cell therapy or until study completion. Information on adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter. Patients were routinely screening for anticipated adverse events. The screening was performed every 6 weeks until the first 3 months and hereafter every 3 months for up to 2.5 years.
Hepatobiliary disorders Elevated liver enzymes	16.0% 4/25 • Number of events 4 • The data was collected throughout the duration of the clinical trial. From October 2017 and until study Completion in july, 2020. For the individual patient, the reporting started at the study enrolment and ended with study exclusion but with a minimum of 6 months follow-up after the adoptive cell therapy or until study completion. Information on adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter. Patients were routinely screening for anticipated adverse events. The screening was performed every 6 weeks until the first 3 months and hereafter every 3 months for up to 2.5 years.
Infections and infestations Infections	24.0% 6/25 • Number of events 6 • The data was collected throughout the duration of the clinical trial. From October 2017 and until study Completion in july, 2020. For the individual patient, the reporting started at the study enrolment and ended with study exclusion but with a minimum of 6 months follow-up after the adoptive cell therapy or until study completion. Information on adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter. Patients were routinely screening for anticipated adverse events. The screening was performed every 6 weeks until the first 3 months and hereafter every 3 months for up to 2.5 years.
Skin and subcutaneous tissue disorders Dry skin	20.0% 5/25 • Number of events 8 • The data was collected throughout the duration of the clinical trial. From October 2017 and until study Completion in july, 2020. For the individual patient, the reporting started at the study enrolment and ended with study exclusion but with a minimum of 6 months follow-up after the adoptive cell therapy or until study completion. Information on adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter. Patients were routinely screening for anticipated adverse events. The screening was performed every 6 weeks until the first 3 months and hereafter every 3 months for up to 2.5 years.
Skin and subcutaneous tissue disorders Granuloma	20.0% 5/25 • Number of events 5 • The data was collected throughout the duration of the clinical trial. From October 2017 and until study Completion in july, 2020. For the individual patient, the reporting started at the study enrolment and ended with study exclusion but with a minimum of 6 months follow-up after the adoptive cell therapy or until study completion. Information on adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter. Patients were routinely screening for anticipated adverse events. The screening was performed every 6 weeks until the first 3 months and hereafter every 3 months for up to 2.5 years.
Musculoskeletal and connective tissue disorders Muscle/joint pain	16.0% 4/25 • Number of events 7 • The data was collected throughout the duration of the clinical trial. From October 2017 and until study Completion in july, 2020. For the individual patient, the reporting started at the study enrolment and ended with study exclusion but with a minimum of 6 months follow-up after the adoptive cell therapy or until study completion. Information on adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter. Patients were routinely screening for anticipated adverse events. The screening was performed every 6 weeks until the first 3 months and hereafter every 3 months for up to 2.5 years.
Psychiatric disorders Hallucinations	16.0% 4/25 • Number of events 4 • The data was collected throughout the duration of the clinical trial. From October 2017 and until study Completion in july, 2020. For the individual patient, the reporting started at the study enrolment and ended with study exclusion but with a minimum of 6 months follow-up after the adoptive cell therapy or until study completion. Information on adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter. Patients were routinely screening for anticipated adverse events. The screening was performed every 6 weeks until the first 3 months and hereafter every 3 months for up to 2.5 years.
Nervous system disorders Vertigo	8.0% 2/25 • Number of events 2 • The data was collected throughout the duration of the clinical trial. From October 2017 and until study Completion in july, 2020. For the individual patient, the reporting started at the study enrolment and ended with study exclusion but with a minimum of 6 months follow-up after the adoptive cell therapy or until study completion. Information on adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter. Patients were routinely screening for anticipated adverse events. The screening was performed every 6 weeks until the first 3 months and hereafter every 3 months for up to 2.5 years.
Renal and urinary disorders Hyponatremia	12.0% 3/25 • Number of events 3 • The data was collected throughout the duration of the clinical trial. From October 2017 and until study Completion in july, 2020. For the individual patient, the reporting started at the study enrolment and ended with study exclusion but with a minimum of 6 months follow-up after the adoptive cell therapy or until study completion. Information on adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter. Patients were routinely screening for anticipated adverse events. The screening was performed every 6 weeks until the first 3 months and hereafter every 3 months for up to 2.5 years.
Respiratory, thoracic and mediastinal disorders Dyspnea	60.0% 15/25 • Number of events 18 • The data was collected throughout the duration of the clinical trial. From October 2017 and until study Completion in july, 2020. For the individual patient, the reporting started at the study enrolment and ended with study exclusion but with a minimum of 6 months follow-up after the adoptive cell therapy or until study completion. Information on adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter. Patients were routinely screening for anticipated adverse events. The screening was performed every 6 weeks until the first 3 months and hereafter every 3 months for up to 2.5 years.
Immune system disorders Autoimmune reactions	24.0% 6/25 • Number of events 8 • The data was collected throughout the duration of the clinical trial. From October 2017 and until study Completion in july, 2020. For the individual patient, the reporting started at the study enrolment and ended with study exclusion but with a minimum of 6 months follow-up after the adoptive cell therapy or until study completion. Information on adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter. Patients were routinely screening for anticipated adverse events. The screening was performed every 6 weeks until the first 3 months and hereafter every 3 months for up to 2.5 years.
General disorders Fever	72.0% 18/25 • Number of events 27 • The data was collected throughout the duration of the clinical trial. From October 2017 and until study Completion in july, 2020. For the individual patient, the reporting started at the study enrolment and ended with study exclusion but with a minimum of 6 months follow-up after the adoptive cell therapy or until study completion. Information on adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter. Patients were routinely screening for anticipated adverse events. The screening was performed every 6 weeks until the first 3 months and hereafter every 3 months for up to 2.5 years.

Additional Information

Anders Kverneland, MD, PhD

National Center for Cancer Immune Therapy, Herlev Hospital

Phone: +4538686467

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place